Pharmaceutical companies marketing drugs with abuse potential are required to manage the abuse risk, along with other risks, associated with their drugs. A Risk Management Action Plan (RiskMAP) and the implementation thereof, is required by the Food and Drug Administration, as a part of the New Drug Application (NDA) from the Pharmaceutical companies. Post marketing surveillance forms an important part of the RiskMAP to identify the risks associated with the target drug(s).
A. Thomas McLellan, Ph.D. and colleagues at the University of Pennsylvania in 1980 developed the Addiction Severity Index (ASI), a multidimensional assessment tool that is administered via semistructured interview to primarily patients entering substance abuse treatment centers. (McLellan A. T., Luborsky L, Woody G. E. & O'Brien C. P. (1980). An improved diagnostic evaluation instrument for substance abuse patients. The Addiction Severity Index. The Journal of Nervous and Mental abuse patients. The Addiction Severity Index. The Journal of Nervous and Mental Disease. January; 168 (1), 26-33, herein incorporated by reference.). The ASI gathers information on various problem areas of the respondent, including medical status, employment and support status, drug use, alcohol use, legal status, family and social relationships, and psychiatric status. Respondents are asked to answer specific questions about the problems they have experienced both recently—i.e. in the last 30 days—and over their lifetimes. Thus, both urgent concerns and longstanding, chronic problems are identified by the ASI. Respondents can also be asked to rate the extent of their difficulties and their need for treatment including indicating difficulties and needs in the problem areas listed above. Respondents' responses to the ASI inquiries are summarized into composite scores, which are considered to be objective and are used to measure change over time in response to treatment. As a result the ASI has become a standard assessment measure not only in the drug abuse field but also in substance abuse in general.
The ASI is used world-wide and is required in more than 30 states. It has been translated into 13 languages. It has also been expanded to specialized populations such as cocaine-abusing mothers, cocaine-freebase users, opiate dependent people, federal prisoners, psychiatrically ill substance abusers, homeless people, and individuals with antisocial personality disorder.
The ASI was adapted by A. Thomas McLellan, Ph.D. in his DENS software to do post marketing surveillance as a part of the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System, but it suffered several drawbacks. First, the RADARS System consists of proprietary programs, of unknown accuracy or validity with little scientific basis and high cost. Second, for the ASI-DENS data to be meaningful, the clinicians, who conduct interviews of the substance users, require extensive training in administration, scoring and entering data into a database. To ensure reliability and validity of data, this ASI-based system is expensive to administrate, score, and enter. Such cost concerns are significant for clinical facilities in the current era of financial cutbacks for social services. Third, the ASI assessed the abuse of a particular prescription drug without identifying the specific brands, the route of administration, or the source of the drug. Finally, deficient of a centralized system to collect and compute the data on substance abuse from a wide spectrum of locales and groups, the ASI did not permit consolidating the substance abuse data from one treatment community to the next.
Although improvements have been made to eliminate some of these deficiencies in the ASI, there is a need for a substance abuse surveillance system that can provide current substance abuse data and allow third parties to access the data in a user-friendly way.